- Recalling firm
- Bioporto Diagnostics A/S
- Reason for recall
- The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
- Affected products (lot / model / serial)
- Model number: ST101UB / 08787174 190; GTIN code: 5711435000156; Lot-number: 04909125 and 04912125.
- Units affected
- 400 units
- Distribution pattern
- Worldwide - The affected product distribution included the United States and the countries of European Union, Chile, and Hong Kong. No affected product was distributed to Canada; however, Health Canada was notified because the product is registered in Canada.
- Firm location
- Hellerup, Denmark
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2937-2026
- Recall initiated
- May 18, 2026
- FDA classification date
- August 12, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99266
- Last updated on HTM Vibe
- August 26, 2026